- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07689903
The Study, Conducted With 54 Individuals Over the Age of 65, Aimed to Reveal the Advantages and Disadvantages of a Combined Exercise Program Compared to Otago Exercise Alone. (OPEP-SARCOBAL)
Otago Plus Proprioceptive Exercises for Sarcopenia, Frailty, Reaction Time, Balance, Falls, and Physical Performance in Geriatric Individuals
Falls are a leading cause of morbidity and mortality in older adults.
Approximately one-third of individuals over 65 years of age fall each year, and 10-15% of these falls result in serious injury.
Balance disorders, decreased muscle strength, prolonged reaction time, and decreased proprioception are key factors that increase the risk of falls.
One evidence-based intervention to reduce the risk of falls is the Otago Exercise Program, originating in New Zealand.
The program includes strength and balance exercises progressed with ankle weights and walking activities, and has been shown to significantly reduce the incidence of falls in older adults.
Proprioceptive exercises aim to stimulate the sensory system responsible for body position perception and movement control. These exercises contribute to improved balance by enhancing sensorimotor integration.
Although the literature shows positive effects of Otago and proprioceptive exercise programs separately, studies comparing the effectiveness of combining these two approaches on sarcopenia, frailty, balance, falls, reaction time, and physical performance parameters are limited.
The aim of this study is to comparatively evaluate the effects of the Otago exercise program and a program combining Otago and proprioceptive exercises on sarcopenia, frailty, reaction time, balance, falls, and physical performance in geriatric individuals.
It is expected that the findings will contribute to more effective and goal-oriented planning of exercise programs in the geriatric population.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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-
Altındağ
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Ankara, Altındağ, Tyrkiet (Türkiye)
- Hacettepe University
-
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Ældre voksen
Tager imod sunde frivillige
Beskrivelse
Inclusion Criteria:
- 65 years of age or older,
- Able to speak and understand Turkish,
- Have at least a primary school education,
- Be able to respond to simple verbal commands.
Exclusion Criteria:
- Serious musculoskeletal pathology that may affect proprioception (advanced rheumatoid arthritis, severe osteoarthritis, major joint deformity, etc.), Major neurological or systemic disease that may affect proprioception (diabetic neuropathy, Vascular insufficiency, Post-stroke hemiplegia, Parkinson's disease, Inability to respond to commands due to cognitive dysfunction (SMMT <18 points), Severe visual or hearing loss, Lower extremity amputation or having undergone major lower extremity surgery within the last year.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Ingen indgriben: Control Group
No exercise program was applied to the patients in this group.
Only sequential measurements were taken and the results were compared with other groups.
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Eksperimentel: Otago Exercise Group
Only patients in this group received the Otago Exercise Program.
|
There are no studies in the literature that combine proprioceptive exercises with otago exercises.
In our study, we applied these combined exercises for the first time.
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Eksperimentel: OTAGO EXERCISES COMBINED WITH PROPRIOCEPTIVE EXERCISES
Patients in this group received a proprioceptive exercise program in conjunction with the Otago Exercise Program.
|
There are no studies in the literature that combine proprioceptive exercises with otago exercises.
In our study, we applied these combined exercises for the first time.
As an intervention, participants were given exercises to improve their proprioception (sense of joint position, sense of movement, etc.) in addition to the otago exercises.
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Change in Frailty Measured by the Edmonton Frailty Scale (EFS)
Tidsramme: From enrollment to the end of treatment at 6 weeks (18 sessions)
|
The Edmonton Frailty Scale (EFS) assesses 9 domains (cognition, general health, functional independence, social support, medication use, nutrition, mood, continence, functional performance).
Total score ranges from 0 (not frail) to 17 (very severe frailty).
Assessments conducted at baseline (week 0), interim (week 3), and final (week 6) by an experienced physiotherapist.
|
From enrollment to the end of treatment at 6 weeks (18 sessions)
|
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Change in Muscle Strength Measured by Hand Grip and Knee Extension Dynamometry
Tidsramme: From enrollment to the end of treatment at 6 weeks (18 sessions)
|
Hand grip strength measured in kilograms (kg) using a hand dynamometer.
Knee extension strength measured in kilograms (kg) using a hand-held dynamometer.
Assessments conducted at baseline (week 0), interim (week 3), and final (week 6) by an experienced physiotherapist.
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From enrollment to the end of treatment at 6 weeks (18 sessions)
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Change in Physical Performance Measured by the 4-Meter Walking Speed Test
Tidsramme: From enrollment to the end of treatment at 6 weeks (18 sessions)
|
Time (in seconds) to walk 4 meters at usual pace.
Assessed at baseline (week 0), interim (week 3), and final (week 6) by an experienced physiotherapist.
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From enrollment to the end of treatment at 6 weeks (18 sessions)
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Change in Muscle Mass Measured by Gastrocnemius-Soleus Circumference
Tidsramme: From enrollment to the end of treatment at 6 weeks (18 sessions)
|
Calf circumference measured in centimeters (cm) using a tape measure at the maximal girth of the gastrocnemius-soleus complex.
Assessed at baseline (week 0), interim (week 3), and final (week 6) by an experienced physiotherapist.
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From enrollment to the end of treatment at 6 weeks (18 sessions)
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Change in Reaction Time Measured by the Nelson Hand and Foot Reaction Test
Tidsramme: From enrollment to the end of treatment at 6 weeks (18 sessions)
|
Reaction time measured in milliseconds (ms) using the Nelson Hand and Foot Reaction Test.
Assessed at baseline (week 0), interim (week 3), and final (week 6) by an experienced physiotherapist.
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From enrollment to the end of treatment at 6 weeks (18 sessions)
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Change in Peripheral Sensation Measured by Semmes-Weinstein Monofilament Test
Tidsramme: From enrollment to the end of treatment at 6 weeks (18 sessions)
|
Monofilament filament size (log10 force in mg) at which sensation is detected on the foot.
Assessed at baseline (week 0), interim (week 3), and final (week 6) by an experienced physiotherapist.
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From enrollment to the end of treatment at 6 weeks (18 sessions)
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Change in Balance and Falls Measured by Number of Falls and Balance Testing
Tidsramme: From enrollment to the end of treatment at 6 weeks (18 sessions)
|
Falls recorded as total number of falls per participant over 6 weeks.
Balance assessed using a validated balance scale (e.g., Berg Balance Scale or Timed Up and Go test in seconds).
Assessed at baseline (week 0), interim (week 3), and final (week 6).
|
From enrollment to the end of treatment at 6 weeks (18 sessions)
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Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Publikationer og nyttige links
Hjælpsomme links
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 6f3d5fcd4f8d
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-delingstidsramme
IPD-delingsadgangskriterier
IPD-deling Understøttende informationstype
- CSR
Studiedata/dokumenter
-
Studieprotokol
Oplysningskommentarer: https://etikkurul.karatekin.edu.tr/dogrulama/6f3d5fcd4f8d4a2e / https://sbetikkurul.karatekin.edu.tr/
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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